BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2971374 · Received February 4, 2013

    Report

    Report Number
    9611710-2013-00065
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    February 28, 2012
    Report Date
    February 28, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS ISSUE IS DEEMED A SERIOUS MALFUNCTION BECAUSE 'INNER TUBE DELAMINATION' EXPOSES THE PATIENT TO THE POSSIBILITY THAT A BRONCHOSCOPE OR SUCTION CATHETER COULD BECOME 'STUCK' IN THE ENDOTRACHEAL TUBE PUTTING THE PATIENT AT THE RISK OF ALVEOIL COLLAPSE AND/OR OXYGEN DESATURATION WITH PATIENT HAVING TO UNDERGO RE-INTUBATION. THE DEVICE WAS NOT RETURNED TH THE MANUFACTURER BUT WAS EVALUATED BY KCC WHO CONFIRMED THAT THE MATERIAL INSIDE THE TUBE WAS NOT INDUCED DURING THE EXTRUSION PROCESS. THEY FOUND NO EVIDENCE THAT THE MATERIAL WAS PLASTIC OR SYNTHETIC POLYMER. THE MATERIAL RECOVERED FROM THE INTERIOR GAVE A POSITIVE BLUE STAIN RESULT FOR ALBUMIN PROTEINS TESTING, AS DID THE CONTROL SAMPLE OF SKIN. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT (FDA AUDIT-OBSERVATION (B)(4)). THIS COMPLAINT WAS RECEIVED BY (B)(4) ON (B)(6) 2012 FROM (B)(4) FOR PRODUCT ENDOTRACHEAL TUBE SIZE 8.0MM. CUSTOMER COMPLAINING: "THE INSIDE OF THE ETT WAS DISINTEGRATING. THEY SAID IT WAS LIKE MATERIAL WAS PEELING OFF FROM THE INSIDE OF THE TUBE SHAFT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47376 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD 35216 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening